CQV Validation Engineer | GMP Life Sciences

Pinnaql, Inc.; Cincinnati (OH); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Pinnaql is a trusted consulting partner to regulated life sciences companies, delivering deep technical, validation, and quality expertise across the product lifecycle. We seek a Validation Engineer to support CQV activities for facilities, equipment, and processes in GMP-regulated settings, working with cross-functional teams to ensure audit-ready documentation and regulatory compliance.

The successful candidate will have hands-on CQV experience, strong technical writing, and the ability to

Qualifications

• 3+ years of validation, qualification, commissioning, or CQV experience in a regulated life sciences environment.
• Experience in pharmaceutical, biotechnology, medical device, or GMP-regulated industries.
• Strong GMP and validation principles understanding.
• Experience developing or executing validation and qualification protocols.
• Experience with risk-based validation methodologies.
• Strong technical writing and documentation skills.
• Ability to interpret engineering drawings, specifications, procedures, and technical documentation.
• Strong organizational and project management skills.
• Ability to work independently and collaboratively in a project environment.

Responsibilities

• Execute and support CQV activities for regulated life sciences facilities.
• Develop, review, and execute validation documentation (URs, IQ/OQ/PQ, protocols, reports).
• Support qualification of equipment, facilities, utilities, and manufacturing systems.
• Perform protocol execution, data collection, and review qualification results.
• Ensure validation activities meet GMP, FDA, EU GMP standards.
• Participate in risk assessments and apply risk-based validation.
• Support deviations, investigations, CAPA, and change control related to validation projects.
• Review engineering and technical documentation to ensure validation needs are addressed.
• Collaborate with Engineering, QA, Manufacturing, Automation, Facilities, and project stakeholders.
• Track validation deliverables, schedules, open items, milestones.
• Support commissioning activities and transition into formal qualification.
• Ensure validation documentation is complete and audit-ready.
• Participate in client meetings and technical reviews.

Skills

CQV experience

GMP knowledge

Technical writing

Risk-based validation

Project management

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Science or related

Job description

Pinnaql is a trusted consulting partner to regulated life sciences companies, delivering deep technical, validation, and quality expertise across the product lifecycle. We seek a Validation Engineer to support CQV activities for facilities, equipment, and processes in GMP-regulated settings, working with cross-functional teams to ensure audit-ready documentation and regulatory compliance.

The successful candidate will have hands-on CQV experience, strong technical writing, and the ability to